STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS

K133475 · Nexxt Spine, LLC · KWQ · Dec 19, 2013 · Orthopedic

Device Facts

• Record ID: K133475
• Device Name: STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
• Applicant: Nexxt Spine, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Device Story

Struxxure® is an anterior cervical plating system consisting of plates and screws. It provides spinal stabilization as an adjunct to cervical fusion. The system includes plates (1- to 5-levels) and both fixed and variable angle screws in self-tapping and self-drilling versions. Used by surgeons in clinical settings to stabilize the cervical spine. The device is implanted during surgery; it provides mechanical support to the spine to facilitate fusion. Benefits include stabilization of the cervical spine in patients with degenerative or traumatic conditions.

Clinical Evidence

Bench testing only. Mechanical properties were characterized using static and dynamic compression bending and static torsion testing per ASTM F1717. No clinical data was provided.

Technological Characteristics

Materials: Titanium (Grade 4, ASTM F67) and titanium alloy (Ti-6Al-4V ELI, ASTM F136). Design: Plate and screw fixation system. Components: Plates (1- to 5-levels), fixed and variable angle screws (self-tapping and self-drilling).

Indications for Use

Indicated for anterior screw fixation of the cervical spine as an adjunct to fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal stenosis, deformity (kyphosis, lordosis, scoliosis), tumor, pseudarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Blade® Anterior Cervical Plate System (K091936)
• C-Tek® MaxAn™ Anterior Cervical Plate System (K080646)
• ABC2 Cervical Plating System (K050813)

Submission Summary (Full Text)

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# Section 8 – 510(k) Summary

| Date: | 8 November 2013 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Nexxt Spine |
| | 14425 Bergen Blvd, Suite B |
| | Noblesville, IN 46060 |
| | Office: 317.436.7801 |
| | Fax: [phone] |
| Contact Person: | Eric Lintula, Director of Engineering and Regulatory Affairs |
| Trade Names: | Struxxure® |
| Device Classification | Class II |
| Classification Name: | Appliance, fixation, spinal intervertebral body |
| Regulation: | 888.3060 |
| Device Product<br>Code: | KWQ |
| Submission Purpose: | This submission adds the Struxxure® components to the Blade®<br>System of cervical solutions. |
| Device Description: | Struxxure consists of plates and screws in a variety of sizes.<br>Plates from 1- to 5-levels are offered. Fixed and variable angle<br>screws are available in two diameters in both self-tapping and self-<br>drilling versions. |
| Intended Use: | The Struxxure® System is intended for anterior screw fixation of<br>the cervical spine. These implants have been designed to provide<br>stabilization as an adjunct to cervical fusion. Indications for the use<br>of this implant system include degenerative disc disease (defined<br>as neck pain of discogenic origin with the degeneration of the disc<br>confirmed by history and radiographic studies), spondylolisthesis,<br>trauma (i.e., fractures or dislocations), spinal stenosis, deformity<br>(i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or<br>failed previous fusion. |
| Materials: | Struxxure plates and screws are manufactured from titanium<br>(Grade 4) or titanium alloy (Ti-6Al-4V ELI) as described by ASTM<br>F67 and ASTM F136, respectively. |
| Predicate Devices: | Blade® Anterior Cervical Plate System (K091936)'<br>C-Tek® MaxAn™ Anterior Cervical Plate System (K080646)<br>ABC2 Cervical Plating System (K050813) |
| Performance Data: | Static and dynamic compression bending and static torsion per<br>ASTM F1717 was used to characterize the mechanical properties<br>of the Struxxure® components. The mechanical test results<br>demonstrate Struxxure® to be substantially equivalent to the<br>predicate devices. |

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## Technological Characteristics:

The Struxxure® components possess the same technological characteristics as the predicates. These include:

- basic design (plate and screw fixation system), .
- material (titanium and titanium alloy), .
- sizing: sizes (diameter and lengths) are within the range of . those offered in the predicate systems, and
- . anatomic location.

Therefore the fundamental scientific technology of the Struxxure® System is the same as previously cleared devices.

In comparison to the predicate devices, the Struxxure® Cervical Plates and Screws have

- the same intended use (as described above), .
- the same technological characteristics (as described above) .

Therefore the Struxxure® System can be found substantially equivalent to the predicate devices.

#### Conclusion:

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three arms or extensions reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2013

Nexxt Spine LLC Mr. Eric Lintula Director of Engineering and Regulatory Affairs 14425 Bergen Boulevard. Suite B Noblesville, Indiana 46060

Re: K133475

Trade/Device Name: Struxxure® Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 22, 2013 Received: November 25. 2013

Dear Mr. Lintula:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Mr. Eric Lintula

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

# Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 7 - Indications for Use Statement

510(k) Number: K133475

Device Name: Struxxure®

Indications for Use:

The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Prescription Use X

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of